Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

NCT06106633 | Terminated DMC FDA Device

• 1 other identifier: 2023P002406
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Conditions

Uterine Bleeding; Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  The Visual Analog Scale (VAS) Pain score will be used to assess pre- and post-procedural pain. The scale is from 1 to 10 with 1 indicating no pain and 10 indicating extreme pain.

  6 months

Secondary Outcomes (1)

• ovarian perfusion

  6 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Patient will undergo UFE using PEDD

Device: TriNaV

Interventions

TriNaV DEVICE

Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, aged \>18 years.
• Prior clinical decision for treatment by UFE.
• One or more enhancing intramural, submucosal or subserosal fibroids on MRI.
• Having either bulk symptoms or menorrhagia.

You may not qualify if:

• Absolute contraindication to contrast-enhanced MRI.
• Current pregnancy.
• Known history of adenomyosis.
• Diagnosis of pelvic inflammatory disease.
• Diagnosis of endometriosis.
• Post-menopausal (no menses \>12-months).
• Diagnosed gynecologic malignancy.
• Prior uterine fibroid embolization treatment.
• \>50% volume of non-enhancing fibroids.
• Prior oophorectomy
• GnRH agonist therapy within 6-months or GnRH antagonist therapy within 1-month prior to entering the study.
• Target uterine vasculature not suitable for treatment with the TriNav Infusion System.
• Allergy or intolerance to dilaudid.
• Lack of ovarian perfusion on baseline MRI.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• TriSalus Life Sciences, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Leiomyoma

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Dania Daye, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: February 9, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 20, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)